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the hatch waxman act how it changed the pharma industry

The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law which encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States. Representative Henry Waxman of California and Senator Orrin Hatch of Utah sponsored the act.

Although the Federal Food, Drug, and Cosmetic Act made it possible for generic companies to get regulatory approval for drugs by filing an Abbreviated New Drug Application (ANDA), in the early 1980s it became clear that very few generics were coming to market. Congress studied the issue and realized that under patent and regulatory law, it was easy for innovator companies to make it difficult for generic companies to successfully file ANDAs and that the regulatory pathway to get ANDAs approved was irregular and uncertain. In response, the Hatch-Waxman Act was negotiated and enacted